DUBLIN, May 19, 2014 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced today that affiliates of the company have completed the acquisition of worldwide rights to Sumavel® DosePro® (sumatriptan injection), a needle-free delivery system for subcutaneous use, from Zogenix, Inc, for $85 million in cash and rights to additional cash payments based on the achievement of certain commercial milestones. In addition, Endo will assume an existing third party royalty obligation on net sales. The transaction will be financed with Endo’s current cash on hand.
Sumavel DosePro is a prescription medicine, given with a needle-free delivery system for the acute treatment of migraine, with or without aura, or cluster headaches in adults. In clinical studies, relief started within 10 minutes for some patients following self-administration, with most achieving relief within 1 or 2 hours. A burst of air delivers sumatriptan just under the skin in less than a second. Sumavel DosePro is designed to be used in just 3 simple steps: SNAP, FLIP, PINCH & PRESS. In a study evaluating ease of use, 51 out of 52 people used Sumavel DosePro correctly the first time with little instruction during a migraine attack.
IMPORTANT SAFETY INFORMATION
SUMAVEL DosePro is contraindicated in patients with:
- Ischemic coronary artery disease (CAD) (e.g. angina pectoris, history of myocardial infarction, or documented silent ischemia), or coronary artery vasospasm, including Prinzmetal’s angina
- Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack (TIA) because these patients are at a higher risk of stroke
- History of hemiplegic or basilar migraine
- Peripheral vascular disease
- Ischemic bowel disease
- Uncontrolled hypertension
- Recent use (i.e., within 24 hours) of another 5-HT1 agonist, an ergotamine containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide
- Concurrent use of a MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor
- Hypersensitivity to Sumavel DosePro (angioedema and anaphylaxis seen)
There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of SUMAVEL DosePro. SUMAVEL DosePro may cause coronary artery vasospasm (Prinzmetal’s angina). These types of reactions have occurred in some patients without known CAD.
For triptan-naive patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating the first SUMAVEL DosePro dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following SUMAVEL DosePro administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of SUMAVEL DosePro.
Life-threatening arrythmias have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue SUMAVEL DosePro if these disturbances occur.
Sensations of tightness, pain, pressure, and heaviness have been reported in the chest, throat, neck, and jaw after treatment with SUMAVEL DosePro and are usually non-cardiac in origin.
Cerebrovascular events, some fatal; non-coronary vasospastic reactions such as peripheral or gastrointestinal vascular ischemia and Raynaud’s syndrome; and increases in blood pressure have been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with SUMAVEL DosePro.
Overuse of acute migraine drugs may lead to exacerbation of headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary.
Serotonin syndrome may occur with SUMAVEL DosePro particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MOA) inhibitors. Discontinue SUMAVEL DosePro if serotonin syndrome is suspected.
In controlled clinical trials with sumatriptan injection, the most common adverse reactions (5% and > placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.
Please see full Prescribing Information for Sumavel DosePro at www.sumaveldosepro.com
About Endo International plc
Endo International plc is a global specialty healthcare company focused on improving patients’ lives while creating shareholder value. Endo develops, manufactures, markets, and distributes quality branded pharmaceutical, generic and device products through its operating companies. Endo has global headquarters in Dublin, Ireland, and US headquarters in Malvern, PA. Learn more at www.endo.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may,” “look forward,” “intend,” “guidance,” “future” or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Risks and uncertainties include the degree to which, if any, the transaction will be accretive to Endo and whether any of the net sales milestones for Sumavel DosePro will be achieved. Investors should note that many factors, as more fully described under the caption “Risk Factors” in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
SOURCE Endo International plc
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